Benicar is manufactured by Daiichi Sankyo, a global pharmaceutical holding company and the second largest drug company in Japan. Currently the pharmaceutical giant is fighting dozens of lawsuits which allege Daiichi Sankyo failed to adequately warn about the potential dangers of Benicar, which has been linked to serious gastrointestinal conditions.
In July of 2013 the U.S. Food and Drug Administration (FDA) issued a warning reporting that the popular high blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe gastrointestinal issues, specifically sprue-like enteropathy. The FDA reported there was “clear evidence of an association between olmesartan and sprue-like enteropathy.” The FDA further suggested that patients who had these conditions should discontinue use of the medication immediately and begin therapy with another antihypertensive. Patients who did stop taking the medication improved immediately.
After the FDA issued their warning about Benicar, lawsuits were filed against Daiichi Sankyo, the manufacturer who had spent an estimated $1 billion promoting the popular drug. Claimants argued they were not adequately warned about potential health issues such as severe, chronic diarrhea with substantial weight loss. In 2014 a motion was filed with the US Judicial Panel on Multidistrict Litigation to consolidate the Benicar lawsuits. If the motion is granted it could consolidate 15 federal cases and 30 state cases in New Jersey in the Northern District of Ohio. The motion also notes that more Benicar lawsuits are likely to be filed alleging that “Benicar was defective and unreasonably dangerous for patients to take, resulting in serious health problems.”
Daiichi Sankyo was founded in 2005 with the merger of Sankyo and Daiichi Pharmaceutical, but the original companies were created through a joint venture in 1899 by Matasaku Shiobara, Shotaro Nishimura and Genjiro Fukui. The drug Benicar was sold in the United States by Sankyo before the merger in 2002, but the manufacturing and marketing have continued through the joint holding company Sankyo Co., Ltd.
Sales of the popular high blood pressure medications dipped after the negative reports were issued by the FDA, but despite the reports, Benicar remains one of the top selling angiotensin receptor blockers. Trouble is looming, however, for the Japanese pharmaceutical company. In 2016 they will lose exclusive rights to the patent for Benicar and will face fierce competition from Mylan Pharmaceuticals who will have the right to sell the drug exclusively for the first 180 days after the patent expires.
Although Benicar, also called Olmesartan, was approved for commercial sale by the FDA in 2002, reports indicate that taking Benicar may lead to serious side-effects including diarrhea, nausea, vomiting, headache, difficulty breathing or swallowing, and coughing. Other users have developed more severe side-effects and intestinal conditions including severe vomiting, severe weight loss, chronic diarrhea, and malnutrition.
Unfortunately, some of the most severe side-effects were unknown until 2012 when the Mayo Clinic reported they had found an association between Benicar and a condition known as spruelike enteropathy. Additional warnings were soon issued by the FDA, including an updated warning label for Benicar. Unfortunately, the warnings were too late for many patients who had already developed severe intestinal issues.